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WO2005004849A3 - Formulation pharmaceutique - Google Patents

Formulation pharmaceutique Download PDF

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Publication number
WO2005004849A3
WO2005004849A3 PCT/EP2004/007667 EP2004007667W WO2005004849A3 WO 2005004849 A3 WO2005004849 A3 WO 2005004849A3 EP 2004007667 W EP2004007667 W EP 2004007667W WO 2005004849 A3 WO2005004849 A3 WO 2005004849A3
Authority
WO
WIPO (PCT)
Prior art keywords
formulation
pharmaceutical formulation
levothyroxine sodium
amount
total weight
Prior art date
Application number
PCT/EP2004/007667
Other languages
English (en)
Other versions
WO2005004849A2 (fr
Inventor
Malgorzata Konieczna
Heiner Krohn
Wanda Roman
Hendrik Schlehahn
Malgorzata Anna Strozyk
Original Assignee
Glaxo Group Ltd
Malgorzata Konieczna
Heiner Krohn
Wanda Roman
Hendrik Schlehahn
Malgorzata Anna Strozyk
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to JP2006518170A priority Critical patent/JP4880457B2/ja
Priority to DE602004018142T priority patent/DE602004018142D1/de
Priority to EP04740922A priority patent/EP1643976B1/fr
Priority to NZ544174A priority patent/NZ544174A/en
Priority to US10/564,148 priority patent/US7955621B2/en
Priority to DK04740922T priority patent/DK1643976T3/da
Priority to BRPI0412391A priority patent/BRPI0412391B8/pt
Priority to MXPA06000353A priority patent/MXPA06000353A/es
Priority to KR1020067000484A priority patent/KR101136655B1/ko
Application filed by Glaxo Group Ltd, Malgorzata Konieczna, Heiner Krohn, Wanda Roman, Hendrik Schlehahn, Malgorzata Anna Strozyk filed Critical Glaxo Group Ltd
Priority to CA2531853A priority patent/CA2531853C/fr
Priority to PL04740922T priority patent/PL1643976T3/pl
Priority to AU2004255466A priority patent/AU2004255466B2/en
Publication of WO2005004849A2 publication Critical patent/WO2005004849A2/fr
Publication of WO2005004849A3 publication Critical patent/WO2005004849A3/fr
Priority to IL172619A priority patent/IL172619A/en
Priority to NO20060208A priority patent/NO338465B1/no
Priority to IS8287A priority patent/IS2616B/is
Priority to HK06109617.8A priority patent/HK1089094A1/xx

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne une formulation pharmaceutique stable comprenant (a) une dose efficace de sodium de lévothyroxine, (b) de la cellulose microcristalline de dimension particulaire moyenne inférieure à 125 νm et présente en dose de 60 à 85 % en poids sur la base du poids total de la formulation, et (c) de l'amidon prégélatinisé présent en dose de 5 à 30 % en poids sur la base du poids total de ladite formulation. L'invention concerne enfin un procédé de préparation d'une telle formulation.
PCT/EP2004/007667 2003-07-10 2004-07-08 Formulation pharmaceutique WO2005004849A2 (fr)

Priority Applications (16)

Application Number Priority Date Filing Date Title
KR1020067000484A KR101136655B1 (ko) 2003-07-10 2004-07-08 레보타이록신 나트륨을 포함하는 제약 제제
EP04740922A EP1643976B1 (fr) 2003-07-10 2004-07-08 Formulation pharmaceutique comprenant du levothyroxine sodium
CA2531853A CA2531853C (fr) 2003-07-10 2004-07-08 Formulation pharmaceutique comprenant du sodium de levothyroxine
US10/564,148 US7955621B2 (en) 2003-07-10 2004-07-08 Pharmaceutical formulation comprising levothyroxine sodium
DK04740922T DK1643976T3 (da) 2003-07-10 2004-07-08 Farmaceutisk formulering omfattende levothyroxinnatrium
BRPI0412391A BRPI0412391B8 (pt) 2003-07-10 2004-07-08 formulação farmacêutica compreendendo levotiroxina sódica, seu uso e processo para sua preparação e
MXPA06000353A MXPA06000353A (es) 2003-07-10 2004-07-08 Formulacion farmaceutica que comprende levotiroxina sodica.
JP2006518170A JP4880457B2 (ja) 2003-07-10 2004-07-08 レボチロキシンナトリウムを含む医薬処方
NZ544174A NZ544174A (en) 2003-07-10 2004-07-08 Pharmaceutical formulation comprising levothyroxine sodium
DE602004018142T DE602004018142D1 (de) 2003-07-10 2004-07-08 Pharmazeutische formulierung mit levothyroxin-natrium
PL04740922T PL1643976T3 (pl) 2003-07-10 2004-07-08 Kompozycja farmaceutyczna zawierająca lewotyroksynę sodową
AU2004255466A AU2004255466B2 (en) 2003-07-10 2004-07-08 Pharmaceutical formulation comprising levothyroxine sodium
IL172619A IL172619A (en) 2003-07-10 2005-12-15 Pharmaceutical formulations comprising (a) levothyroxine sodium, (b) micro crystalline cellulose, and (c) pregelatinised starch, use thereof in the manufacture of medicaments for the treatment of thyroid hormone disorders in a mammal and a process for preparing said pharmaceutical formulations
NO20060208A NO338465B1 (no) 2003-07-10 2006-01-13 Farmasøytisk preparat omfattende levotyroksinnatrium, fremgangsmåte for fremstilling samt anvendelse derav
IS8287A IS2616B (is) 2003-07-10 2006-02-07 Lyfjablanda sem felur í sér levóþýroxínnatríum
HK06109617.8A HK1089094A1 (en) 2003-07-10 2006-08-29 Pharmaceutical formulation comprising levothyroxine sodium

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0316206.2A GB0316206D0 (en) 2003-07-10 2003-07-10 Pharmaceutical formulation
GB0316206.2 2003-07-10

Publications (2)

Publication Number Publication Date
WO2005004849A2 WO2005004849A2 (fr) 2005-01-20
WO2005004849A3 true WO2005004849A3 (fr) 2005-05-06

Family

ID=27741962

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2004/007667 WO2005004849A2 (fr) 2003-07-10 2004-07-08 Formulation pharmaceutique

Country Status (29)

Country Link
US (1) US7955621B2 (fr)
EP (1) EP1643976B1 (fr)
JP (2) JP4880457B2 (fr)
KR (1) KR101136655B1 (fr)
CN (1) CN100430051C (fr)
AR (1) AR045719A1 (fr)
AT (1) ATE415949T1 (fr)
AU (1) AU2004255466B2 (fr)
BR (1) BRPI0412391B8 (fr)
CA (1) CA2531853C (fr)
CO (1) CO5700710A2 (fr)
DE (1) DE602004018142D1 (fr)
DK (1) DK1643976T3 (fr)
ES (1) ES2319193T3 (fr)
GB (1) GB0316206D0 (fr)
HK (1) HK1089094A1 (fr)
IL (1) IL172619A (fr)
IS (1) IS2616B (fr)
MA (1) MA27898A1 (fr)
MX (1) MXPA06000353A (fr)
MY (1) MY140127A (fr)
NO (1) NO338465B1 (fr)
NZ (1) NZ544174A (fr)
PL (1) PL1643976T3 (fr)
PT (1) PT1643976E (fr)
RU (1) RU2349345C2 (fr)
TW (1) TWI329026B (fr)
WO (1) WO2005004849A2 (fr)
ZA (1) ZA200510224B (fr)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMI20022394A1 (it) 2002-11-13 2004-05-14 Bracco Spa Uso di triiodotironina 3-solfato come farmaco ad attivita' tireomimetica e relative formulazioni farmaceutiche.
ITMI20110713A1 (it) 2011-04-29 2012-10-30 Bracco Imaging Spa Processo per la preparazione di un derivato solfatato di3,5-diiodo-o-[3-iodofenil]-l-tirosina
EP1973524B1 (fr) * 2006-01-06 2011-08-10 Intervet International BV Composition d'hormone thyroidienne liquide concentree
IT1395454B1 (it) * 2009-03-24 2012-09-21 Altergon Sa Composizioni e forme farmaceutiche per somministrazione orale di ormoni tiroidei in grado di contrastare l'azione di agenti sequestranti nel tratto gastrointestinale
ITMI20112066A1 (it) * 2011-11-14 2013-05-15 Altergon Sa Preparazione farmaceutica orale monodose di ormoni tiroidei t3 e t4
WO2014098887A1 (fr) * 2012-12-21 2014-06-26 Mylan Inc. Formulation de lévothyroxine avec de la gomme arabique
WO2014098886A1 (fr) * 2012-12-21 2014-06-26 Mylan Inc. Formulation de lévothyroxine avec de la carraghénine
US9271951B2 (en) 2012-12-21 2016-03-01 Mylan Inc. Levothyroxine formulation with acacia
EP2932963A1 (fr) 2014-04-16 2015-10-21 Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. Stables firmes galéniques contenant du Lévothyroxine de Sodium
KR102488488B1 (ko) 2015-10-07 2023-01-12 쿄와 기린 가부시키가이샤 아릴알킬아민 화합물 함유 의약 조성물
JP6168673B2 (ja) 2015-10-07 2017-07-26 協和発酵キリン株式会社 アリールアルキルアミン化合物含有医薬組成物
WO2018069805A2 (fr) 2016-10-10 2018-04-19 Ftf Pharma Private Limited Procédé de préparation d'une composition liquide de l-thyroxine à usage oral
MD3576795T2 (ro) * 2017-02-03 2021-08-31 Berlin Chemie Ag Medicament peroral pentru tratamentul glandei tiroide
IT201800003615A1 (it) * 2018-03-15 2019-09-15 Altergon Sa Formulazioni altamente stabili di ormone tiroideo in capsule molli
CN118894787A (zh) * 2019-05-05 2024-11-05 上海葆隆生物科技有限公司 一种左甲状腺素钠杂质及其制备
KR20220085086A (ko) 2020-12-14 2022-06-22 메디케어제약 주식회사 갑상선 기능 저하증을 동반한 대사 증후군을 치료하는 약제학적 복합제제

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995020954A1 (fr) * 1994-02-01 1995-08-10 Knoll Ag Comprimes contenant des hormones thyroidiennes
US5955105A (en) * 1995-11-14 1999-09-21 Knoll Pharmaceutical Company Stabilized thyroid hormone preparations and methods of making same
US5958979A (en) * 1995-10-27 1999-09-28 Henning Berlin Gmbh & Co. Stabilized medicaments containing thyroid hormones
US6190696B1 (en) * 1998-06-08 2001-02-20 Pieter J. Groenewoud Stabilized thyroxine medications
WO2001074448A1 (fr) * 2000-03-30 2001-10-11 Mova Pharmaceutical Corporation Preparations stables d'hormones thyroidiennes et leur procede de fabrication
US6555581B1 (en) * 2001-02-15 2003-04-29 Jones Pharma, Inc. Levothyroxine compositions and methods

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5225204A (en) * 1991-11-05 1993-07-06 Chen Jivn Ren Stable dosage of levothyroxine sodium and process of production
WO1994006309A1 (fr) * 1992-09-22 1994-03-31 Fmc Corporation Produit et procede de production de cellulose microcristalline
JPH11286456A (ja) * 1998-03-31 1999-10-19 Lion Corp 複合粉体組成物及び錠剤
DE19821625C1 (de) * 1998-05-15 2000-01-05 Merck Patent Gmbh Pharmazeutische Zubereitung
JP2001064177A (ja) * 1999-08-16 2001-03-13 Schering Ag ベンズアミド誘導体を有効成分とする製剤
JP3435664B2 (ja) 1999-12-08 2003-08-11 ヤンセンファーマ株式会社 口腔内速崩壊型錠剤及びその製造方法
US20030032675A1 (en) * 2001-02-15 2003-02-13 Franz G. Andrew Manufacture of thyroid hormone tablets having consistent active moiety amounts

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995020954A1 (fr) * 1994-02-01 1995-08-10 Knoll Ag Comprimes contenant des hormones thyroidiennes
US5958979A (en) * 1995-10-27 1999-09-28 Henning Berlin Gmbh & Co. Stabilized medicaments containing thyroid hormones
US5955105A (en) * 1995-11-14 1999-09-21 Knoll Pharmaceutical Company Stabilized thyroid hormone preparations and methods of making same
US6190696B1 (en) * 1998-06-08 2001-02-20 Pieter J. Groenewoud Stabilized thyroxine medications
WO2001074448A1 (fr) * 2000-03-30 2001-10-11 Mova Pharmaceutical Corporation Preparations stables d'hormones thyroidiennes et leur procede de fabrication
US6555581B1 (en) * 2001-02-15 2003-04-29 Jones Pharma, Inc. Levothyroxine compositions and methods

Also Published As

Publication number Publication date
JP4880457B2 (ja) 2012-02-22
CN100430051C (zh) 2008-11-05
CN1819820A (zh) 2006-08-16
EP1643976A2 (fr) 2006-04-12
ZA200510224B (en) 2007-09-26
JP2009513530A (ja) 2009-04-02
CO5700710A2 (es) 2006-11-30
JP2011213736A (ja) 2011-10-27
MY140127A (en) 2009-11-30
MA27898A1 (fr) 2006-05-02
EP1643976B1 (fr) 2008-12-03
AR045719A1 (es) 2005-11-09
KR101136655B1 (ko) 2012-04-18
AU2004255466B2 (en) 2007-07-26
NO338465B1 (no) 2016-08-22
HK1089094A1 (en) 2006-11-24
BRPI0412391A (pt) 2006-09-19
PT1643976E (pt) 2009-03-03
IS2616B (is) 2010-04-15
MXPA06000353A (es) 2006-03-28
KR20060065628A (ko) 2006-06-14
AU2004255466A1 (en) 2005-01-20
ES2319193T3 (es) 2009-05-05
IS8287A (is) 2006-02-07
CA2531853A1 (fr) 2005-01-20
GB0316206D0 (en) 2003-08-13
IL172619A0 (en) 2006-04-10
ATE415949T1 (de) 2008-12-15
NO20060208L (no) 2006-01-13
WO2005004849A2 (fr) 2005-01-20
DK1643976T3 (da) 2009-04-06
CA2531853C (fr) 2010-09-14
TW200518785A (en) 2005-06-16
US7955621B2 (en) 2011-06-07
NZ544174A (en) 2008-07-31
PL1643976T3 (pl) 2009-05-29
TWI329026B (en) 2010-08-21
BRPI0412391B8 (pt) 2021-05-25
IL172619A (en) 2010-12-30
RU2006104009A (ru) 2006-06-27
US20070110803A1 (en) 2007-05-17
DE602004018142D1 (de) 2009-01-15
BRPI0412391B1 (pt) 2017-10-31
RU2349345C2 (ru) 2009-03-20

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